Preoperative Inspiratory Muscle Training in Esophageal Resection (PREPARE)

Preoperative Inspiratory Muscle Training to Prevent Postoperative Pneumonia in Patients Undergoing Esophageal Resection

The PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection.

Study Overview

• Status: Completed
• Conditions: Esophageal Resection Candidates
• Intervention / Treatment: Other: Inspiratory Muscle Training (IMT)

Detailed Description

Rationale: Esophageal resection is associated with high incidences of postoperative pulmonary pneumonia. Numbers of 30% are reported in literature. Postoperative complications can result in prolonged hospital stay and increased health care costs. In cardiac surgery patients a reduction of postoperative pneumonia of 50% is reported as a result of a preoperative inspiratory muscle training program. While in some surgical centers IMT is already used in the preoperative phase in patients undergoing esophageal resection, the effect of this promising intervention has not yet been investigated in a randomised and controlled study design in large surgical populations other than cardiac surgery.

Primary objective: Investigate the effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection.

Study design: Prospective multicenter randomised controlled clinical trial.

Main study parameters/endpoints: A significant reduction in incidence of postoperative pneumonia.

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • University Hospital Gasthuisberg
• Finland
  • Helsinki, Finland
    • HUS
• Ireland
  • Dublin, Ireland
    • St. James's Hospital
• Netherlands
  • Almelo, Netherlands
    • Zorggroep Twente
  • Amsterdam, Netherlands
    • VU Medical Center
  • Delft, Netherlands
    • Reinier de Graaf Gasthuis
  • Heerlen, Netherlands
    • Atrium Medical Center
  • Nijmegen, Netherlands
    • Canisius Wilhelmina Hospital
  • Utrecht, Netherlands
    • UMC Utrecht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (Cognitively) capable to understand and perform a preoperative IMT program
• Surgery is scheduled at least 2 weeks after signing informed consent, since the patients need to be able to follow the intervention program for at least 2 weeks
• Willing to sign the informed consent form

Exclusion Criteria:

• Unable to communicate in Dutch language
• Age < 18 years
• Participating in a conflicting trial concerning esophageal resection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Usual care + Inspiratory Muscle Training (IMT)	Other: Inspiratory Muscle Training (IMT); The IMT protocol is tailored individually. Inspiratory load is set at 60% of the measured maximal inspiratory pressure (Pimax). The load is incrementally increased based on the rate of perceived exertion (RPE) scored on a scale from 0 to 10 which is scored by the patient after each training session. When patients score an RPE below 7, patients increase the inspiratory load of the threshold device with 5% to guarantee overload during each training session. Patients have to complete 30 dynamic inspiratory efforts twice daily. Patients will be instructed to train at home 7 days a week until surgery with a minimum of 2 weeks. Training will be started after the chemoradiation period (if applicable).
No Intervention: Usual care (no IMT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumonia incidence	Pneumonia will be scored according to the Utrecht Pneumonia Scoring System.	Date of first pneumonia event. Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Postoperative length of stay on the intensive care unit, Postoperative length of hospital stay.	Time between date of surgery and first discharge from ICU and first discharge from hospital (on average 14 days)
Duration of mechanical ventilation	Number of hours spent on the mechanical ventilator during and directly following the primary surgery.	Time between intubation and first extubation (in general no more then 24 hours)
Respiratory muscle function	Inspiratory muscle endurance and maximal inspiratory pressure at the mouth (Pi-max).	At baseline, before surgery and 3, 6 and 9 days after surgery.
Pulmonary function	Forced Expiratory Volume in one second (FEV1), Forced vital capacity (FVC), FEV1/FVC ratio.	At baseline, before surgery and 3, 6 and 9 days after surgery.
Quality of life	Quality of life is measured using the EuroQol and SF-12 questionnaires.	At baseline and 4 weeks after surgery

Collaborators and Investigators

• Sponsor: UMC Utrecht

Publications and helpful links

General Publications

• Valkenet K, Trappenburg JCA, Ruurda JP, Guinan EM, Reynolds JV, Nafteux P, Fontaine M, Rodrigo HE, van der Peet DL, Hania SW, Sosef MN, Willms J, Rosman C, Pieters H, Scheepers JJG, Faber T, Kouwenhoven EA, Tinselboer M, Rasanen J, Ryynanen H, Gosselink R, van Hillegersberg R, Backx FJG. Multicentre randomized clinical trial of inspiratory muscle training versus usual care before surgery for oesophageal cancer. Br J Surg. 2018 Apr;105(5):502-511. doi: 10.1002/bjs.10803.
• Valkenet K, Trappenburg JC, Gosselink R, Sosef MN, Willms J, Rosman C, Pieters H, Scheepers JJ, de Heus SC, Reynolds JV, Guinan E, Ruurda JP, Rodrigo EH, Nafteux P, Fontaine M, Kouwenhoven EA, Kerkemeyer M, van der Peet DL, Hania SW, van Hillegersberg R, Backx FJ. Preoperative inspiratory muscle training to prevent postoperative pulmonary complications in patients undergoing esophageal resection (PREPARE study): study protocol for a randomized controlled trial. Trials. 2014 Apr 27;15:144. doi: 10.1186/1745-6215-15-144.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: June 17, 2013
• First Submitted That Met QC Criteria: July 1, 2013
• First Posted (Estimate): July 8, 2013

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 10, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Surgery; Esophageal cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: NL43194.041.13